Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Not Recruiting

Trial ID: NCT03229200

Purpose

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Official Title

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

Eligibility


Inclusion Criteria:

   - Subject must have participated in an eligible ibrutinib clinical trial, may derive
   clinical benefit from continued treatment or restart of treatment with ibrutinib in
   the opinion of the treating physician and does not have access to commercial ibrutinib
   within their region and/or the drug is not reasonably accessible to the patient within
   the respective region.

   - Ongoing continuous treatment with ibrutinib.

   - Subject must have completed all assessments in their parent protocol and want to
   continue treatment with ibrutinib.

   - Subject or their legally authorized representative must voluntarily sign and date an
   informed consent approved by an independent ethics committee (IEC)/institutional
   review board (IRB) to the long term treatment extension protocol and not withdrawn
   consent from the parent study.

   - Male and female subjects of reproductive potential who agree to use both a highly
   effective method of birth control and a barrier method during the period of therapy
   and for 90 days after the last dose of drug.

Exclusion Criteria:

   - Meeting any requirement in the parent protocol to permanently discontinue ibrutinib
   treatment.

   - Any condition or situation which, in the opinion of the treating physician, may
   interfere significantly with a subject's participation in the protocol.

   - Female subjects who are pregnant, or breastfeeding, or planning to become pregnant
   while enrolled in this protocol or within 90 days of last dose of drug treatment. Male
   subjects who plan to father a child while enrolled in this protocol or within 90 days
   after the last dose of drug treatment.

   - Unwilling or unable to participate in all required evaluations and procedures.

   - Unable to understand the purpose and risks of the protocol and to provide a signed and
   dated informed consent form (ICF) and authorization to use protected health
   information.

Intervention(s):

drug: Ibrutinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amanda Liu
650-725-0437

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